Who decides what food additives are “Generally Recognized as Safe”?

Released today, the report finds the rules that allow ingredients to be considered “Generally Recognized As Safe” (GRAS) now constitute a loophole by which food manufacturers introduce new ingredients into foods without review by the Food and Drug Administration. There are an estimated 10,000 additives that can make it into our foods.

Congress passed the Food Additives Amendment and introduced the “GRAS List” in 1958, to allow ingredients like sugar, salt and vinegar to be used in food products without formal review by the Food and Drug Administration (FDA). However, according to the NRDC’s findings, many companies now determine that newly developed food additives are safe without review.

“NRDC believes that ‘Generally Recognized as SECRET’ rather than ‘Generally Recognized as SAFE’ is a bettername for the GRAS loophole.”

As the law stands, a food manufacturer can use its own employees and scientists to decided if an ingredient is safe to eat. Not only is this potentially a huge conflict of interest, but review by the FDA is only voluntary.

Using Freedom of Information requests, the NRDC reviewed correspondences between the FDA and food manufacturers seeking voluntary approval. They then compared these ingredients with a list of “GRAS Self-Determination Inventory Database.” They identified 398 chemicals used as food additives that have not been reviewed by the FDA. The report characterizes this list of unreviewed chemicals as “the tip of the iceberg.”

Aside from the lack of transparency, what are the real health risks? It can be difficult to prove harm on a short-term basis. However, documents regarding ingredients withdrawn from review give us some troubling glimpses.

If the FDA determines a chemical cannot go on the “GRAS” list, it will post a document to its website explaining its decision. However, if a company withdraws a case from the review process, a chemical may stay in products and the FDA’s concerns won’t be made public. The NRDC’s research found four cases where companies withdrew their products after the FDA raised serious concerns.

One example is theobromine, an ingredient found in isotonic waters, nutrition bars and diet foods. Although the maker determined this product to be GRAS, the FDA expressed concern that the ingredient was associated with testicular degeneration in rats and rabbits and delayed bone formation in rats. The review was subsequently withdrawn by the chemical maker.

Based on the report, the NRDC is calling for changes to the FDA's policies. They’re also asking that consumers “demand that their grocery stores and their favorite brands sell only those food products with ingredients that the FDA has found to be safe.”